An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. One of the unintended consequences of limiting the scope of the guidelines is that it allows CPPs to use them as a pretext to limit the sharing of quality responsibility to the commercial agenda. This certainly facilitates the work of the CDMO, as they have to juggle the differences between each client`s QMS. At a time when accelerated clinical plans are the norm rather than the exception, the need to maintain a practical distribution of quality responsibility during development is critical to a drug sponsor/owner`s ability to deliver a robust CMC and clinical program. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, which are tailored to the relevant aspects of the type of relationship. In addition, the European MMIB guidelines state that “the contract should clearly describe who carries out each stage of the outsourced activity.” B for example, knowledge management, technology transfer, supply chain, outsourcing, quality and supply, material control and release, production and quality controls (including ongoing controls, sampling and analysis). A quality agreement should include at least the following paragraphs: according to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the contract, which defines and defines each party`s production activities in order to comply with CGMP compliance. The agreement should make it clear whether the owner or contracting body (or both) is engaged in certain CGMP activities. (1) It is customary for the trade agreement and the quality agreement to contain provisions on the same subject, such as rights. B audit or technology transfer. It is preferable that there be no duplication and that one of the documents simply refers to the provisions of the other agreement instead of repeating or repeating the same provisions. Iser: The European Commission has published a review of the European Union`s Good Manufacturing Practices (GMP) (Chapter 7) (2) with effect from 2013, in order to provide expectations for subprocessed activities regulated by GMP.